Description
Briefly about the product
Flixonase is a new level in the treatment of allergic rhinitis! *
It is a nasal spray to relieve symptoms of year-round and seasonal allergic rhinitis. The active substance is fluticasone propionate.
Helps relieve symptoms of allergic rhinitis for 24 hours **. Helps combat the 6 symptoms of allergic rhinitis **, such as:
Runny nose
Nasal congestion
Sneezing
Itchy nose
Lacrimation
Sensation of pain and pressure in the sinuses of the nose.
* The first over-the-counter intranasal GCS for the treatment of allergic rhinitis. It has a fundamentally different mechanism of action in comparison with antihistamines.
** Instructions for medical use, RU PN015682 / 01 of 08/08/2009
Description
Nasal spray dosed in the form of an opaque suspension of white color, free from foreign particles.
release form
Nasal Spray
120 doses – yellow glass bottles (1) with a metering device, adapter and protective cap – plastic cases with a booklet label.
Pharmacological action of
GCS for intranasal use. It has a pronounced anti-inflammatory effect. With intranasal administration, there is no systemic effect, practically does not inhibit the hypothalamic-pituitary-adrenal system.
No significant change in the daily AUC of serum cortisol was detected after administration of fluticasone propionate at a dose of 200 μg / day compared with placebo (ratio: 1.01, 90% CI – confidence interval from 0.9 to 1.14).
The anti-inflammatory effect of fluticasone propionate is realized as a result of its interaction with glucocorticoid receptors. Suppresses the proliferation of mast cells, eosinophils, lymphocytes, macrophages, neutrophils.
Fluticasone propionate reduces the production of inflammatory mediators and a number of biologically active substances (including histamine, prostaglandins, leukotrienes, cytokines) during the early and late phases of an allergic reaction. It has a quick anti-inflammatory effect on the nasal mucosa.
The antiallergic effect manifests itself already 2-4 hours after the first application. Reduces sneezing, itching in the nose, rhinorrhea, nasal congestion, discomfort in the paranasal sinuses and a feeling of pressure around the nose and eyes. It also alleviates eye symptoms associated with allergic rhinitis. The decrease in the severity of symptoms (especially nasal congestion) persists for 24 hours after a single application of the spray at a dose of 200 mcg.
Fluticasone propionate improves the quality of life of patients, including physical and social activity.
Indications
Treatment of perennial and seasonal allergic rhinitis, including hay fever (hay fever) in adults and children from 4 years of age: pain, sensation of pressure in the paranasal sinuses, nasal congestion, sneezing, lacrimation in the nose.
Use during pregnancy and lactation
Before using the drug Flixonase ® during pregnancy and lactation, consult your doctor.
Pregnant and lactating women, Flixonase ® can only be prescribed if the expected benefit to the patient outweighs any possible risk to the fetus or child.
Composition
1 dose:
– fluticasone propionate (micronised) 50 .mu.g
Excipients:
dextrose anhydrous,
microcrystalline cellulose,
carboxymethyl cellulose microcrystalline,
phenylethyl alcohol,
rr benzalkonium chloride,
polysorbate 80,
hydrochloric acid diluted,
purified water.
Side effects
Determination of the frequency of side effects: very often ( 1/10), often ( 1/100 and <1/10), infrequently ( 1/1000 and <1/100), rarely ( 1 / 10,000 and <1/1000), very rarely (<1/10 000, including isolated cases). Very often, often and infrequently occurring adverse reactions are mainly established on the basis of clinical trials. Reactions that occur rarely and very rarely are mainly determined from spontaneous messages. When forming the frequency of occurrence of adverse reactions, background indicators in the placebo group were not taken but attention, since they were generally comparable with the active treatment group. From the side of the immune system: very rarely – hypersensitivity reactions, incl. bronchospasm, rash, swelling of the face and tongue, anaphylactic reactions, anaphylactoid reactions. From the side of the nervous system: often – headache, sensation of unpleasant taste and smell. The appearance of a headache, a sensation of unpleasant taste and smell was also reported when using other nasal sprays. From the side of the organ of vision: very rarely – glaucoma, increased intraocular pressure, cataracts. A small number of spontaneous reports were associated with long-term drug therapy. From the respiratory system: very often – nosebleeds often – dry mucous membranes in the nasal cavity and pharynx, irritation of the mucous membrane in the nasal cavity and pharynx (these adverse reactions, as well as nosebleeds, were also observed when using other intranasal preparations) very rarely – perforation of the nasal septum (reported when taking intranasal GCS). With the use of certain intranasal corticosteroids, systemic effects may develop, especially when given in high doses for a long time. Drug Interaction When fluticasone propionate is co-administered with ritonavir, which is a potent inhibitor of the CYP3A4 isoenzyme, possibly a significant increase in the concentration of fluticasone propionate in blood plasma. As a result, there is a sharp decrease in serum cortisol concentration. The use of fluticasone propionate inhalation or intranasal and ritonavir leads to the development of side effects caused by the systemic action of ACS, including Cushing’s syndrome and inhibition of adrenal cortex. Therefore, the concomitant use of fluticasone propionate and ritonavir should be avoided unless the potential benefit outweighs the risk of systemic effects. When fluticasone propionate is co-administered with other less potent CYP3A4 isoenzyme inhibitors such as ketoconazole and itraconazole, leads to increased fluticasone propionate exposure and increased risk of systemic side effects. Caution is advised and, where possible, to avoid long-term joint use of these drugs. CYP3A4 isoenzyme inhibitors cause a small (erythromycin) or a slight (ketoconazole) increase in plasma concentrations of fluticasone propionate, which do not entail any appreciable decrease in serum cortisol. However, caution should be exercised when co-administering CYP3A4 isoenzyme inhibitors (eg, ketoconazole) and fluticasone propionate due to a possible increase in the latter’s plasma concentration. Overdose There is no data on acute and chronic overdose. Intranasal administration to healthy volunteers of 2 mg of fluticasone propionate 2 times / day for 7 days had no effect on the function of the hypothalamic-pituitary-adrenal system (doses 20 times higher than therapeutic). The use of the drug at doses above the recommended dosage for a long time may lead to temporary suppression of adrenal function. In case of overdose, the patient should consult a doctor. Storage conditions The drug should be stored out of the reach of children at a temperature not exceeding 30 ° C. The Expiration of is 3 years. Deystvuyuschee substances fluticasone furoate Dosage form Dosage form nasal spray GlaxoSmithKline, Spain
